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Heart bypass patients: which blood thinner works best to keep grafts open?

NCT ID NCT07195149

Disease control Sponsor: Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether taking two blood thinners (prasugrel plus low-dose aspirin) for three months after heart bypass surgery is better than taking aspirin alone (either low or high dose) at preventing graft failure. About 1,700 adults with stable coronary artery disease who need bypass surgery will participate. The goal is to find the safest and most effective way to keep new blood vessel grafts working long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,703 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A. Baseline (preoperative) inclusion criteria 1. Age \>18 years 2. Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts. Coronary artery disease will be defined as a stenosis ≥ 70% based on coronary angiography, a FFR value ≤ 0.80 or iFr value ≤0.89; a left main diameter stenosis ≥ 50%, left main IVUS MLA value ≤ 6 mm2, or equivalent OCT measurements will also be considered. 3. Ability to comply with all study procedures and follow-up procedures 4. Signed Informed Consent to participate in the study. B. Operative inclusion criteria: 1. Intraoperative graft evaluation using transit time flow measurement in all grafts, normal flow in any graft is defined as mean graft flow \> 15 mL/min with Pulsatility Index \< 5 2. Left anterior descending artery grafted with internal thoracic artery 3. No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel) 4. No endarterectomy of the grafted vessel performed 5. Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention) Exclusion Criteria: A. Baseline (preoperative) exclusion criteria: 1. Cardiogenic shock 2. Patients with recent acute coronary syndrome (ACS) (\<12 months) 3. Single vessel CABG 4. Patients with preoperative atrial fibrillation 5. Dialysis 6. Thrombocytopenia (platelet count \< 100 000 platelets/uL) 7. Anemia (Hemoglobin level \< 10 g/dL) 8. Severe liver failure Child-Pugh classification \>4 9. Known, active infections with HIV, HBV, HCV, tuberculosis 10. Active malignant disease or history of malignancy within the past 5 years 11. Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries) 12. Indication for oral anticoagulant treatment 13 Indications for the use of methotrexate at a dose of 15 mg/week or more 14\. Any contraindication for prasugrel or ASA 15. Planned additional cardiac or non-cardiac surgery within 12 months 16. Non-cardiac co-morbidity with life expectancy less than 12 months 17. History of any bleeding complications due to the use of DAPT 18. History of intracranial bleeding 19. History of gastro-intestinal bleeding 20. Pregnancy or breastfeeding 21. Lack of compliance with the use of a highly effective method of birth control 22. Planned coronary endarterectomy 23. Severe impaired renal function (eGFR \<40mL/min/1.73 m2). B. Postoperative and prior randomization exclusion criteria: 1. Perioperative cardiogenic shock 2. Intraoperative death or death prior randomization 3. Myocardial infarction within 12-24 hours following CABG or prior randomization 4. Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization 5. Any postoperative complication that may increase patients' risk with DAPT 6. Atrial Fibrillation prior randomization 7. Gastro-intestinal bleeding prior randomization

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic coronary syndrome Stable coronary artery disease cad

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central Clinical Hospital of the Ministry of Interior and Administration

    ACTIVE_NOT_RECRUITING

    Warsaw, Poland

  • Institute of Medical Sciences in Opole

    NOT_YET_RECRUITING

    Opole, Poland

  • J. Struś Hospital

    NOT_YET_RECRUITING

    Poznan, Poland

  • John Paul II Hospital

    NOT_YET_RECRUITING

    Krakow, Poland

  • Medical University of Gdansk

    NOT_YET_RECRUITING

    Gdansk, Poland

  • Medical University of Lodz

    NOT_YET_RECRUITING

    Lodz, Poland

  • Medicover Hospital

    RECRUITING

    Warsaw, Poland

  • Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz

    NOT_YET_RECRUITING

    Bydgoszcz, Poland

  • Pomeranian Medical University

    NOT_YET_RECRUITING

    Szczecin, Poland

  • Poznan University of Medical Sciences

    ACTIVE_NOT_RECRUITING

    Poznan, Poland

  • Provincial Specialist Hospital in Olsztyn

    NOT_YET_RECRUITING

    Olsztyn, Poland

  • Regional Specialist Hospital in Grudziadz

    NOT_YET_RECRUITING

    Grudziądz, Poland

  • Silesian Centre for Heart Diseases in Zabrze

    RECRUITING

    Zabrze, Poland

  • University Clinical Hospital in Bialystok

    NOT_YET_RECRUITING

    Bialystok, Poland

  • Upper-Silesian Heart Center

    ACTIVE_NOT_RECRUITING

    Katowice, Poland

  • Wroclaw Medical University

    ACTIVE_NOT_RECRUITING

    Wroclaw, Poland

  • Zbigniew Religa Heart Center "Medinet"

    RECRUITING

    Nowa Sól, Poland

  • Zbigniew Religa Heart Center "Medinet"

    RECRUITING

    Wroclaw, Poland

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